Camrelizumab Combined With Irinotecan or Albumin Paclitax... | NCT05669807

Studies
Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

NCT05669807

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Jan 3, 2023Actual

Enrollment

184Estimated

Phase

Phase 2

Conditions

Second Line Treatment of Gastric Cancer

Interventions

Camrelizumab
Albumin-Bound Paclitaxel
Irinotecan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2022Estimated

Primary Completion Date

Nov 2023Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Nov 28, 2022

First Submission Date that Met QC Criteria

Dec 20, 2022

First Posted Date

Jan 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2022

Last Update Posted Date

Jan 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A: Camrelizumab+Albumin-bound paclitaxel	Experimental	Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days	Drug: Camrelizumab Drug: Albumin-Bound Paclitaxel
B: Camrelizumab+Irinotecan	Experimental	Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle	Drug: Camrelizumab Drug: Irinotecan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Camrelizumab	Drug	200mg d1, the first day, every 14 days as a cycle	A: Camrelizumab+Albumin-bound paclitaxel B: Camrelizumab+Irinotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate	CR+PR	up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Time from random start of treatment to death from any cause	From date of randomization until the date of date of death from any cause, assessed up to 24 months
Progression-free Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18-75
ECOG score: 0 or 1
Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer
histologically proven adenocarcinoma
Received chemotherapy based on platinum and fluorouracil within 12 months
Patients not previously treated with paclitaxel or irinotecan
Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit)
Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min
Echocardiography or radionuclide cardiac function test, LVEF ≥ 50%
Expected survival ≥ 3 months
Sign the informed consent form

Exclusion Criteria:

Patients who have received irinotecan or paclitaxel chemotherapy in the past
ECOG PS score:>2
Advanced gastric cancer patients with extensive and severe peritoneal metastasis
Patients with severe liver and kidney insufficiency or cardiac insufficiency
HIV positive, active hepatitis B or C, active pulmonary tuberculosis
Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc
Patients known to be allergic to any of the study drugs
Pregnant or lactating female patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ji Zhu	Contact	0571-88128142		leo.zhu@126.com
Jinwen Shen	Contact	0571-88128142		shenjw2005@126.com

Name	Affiliation	Role
Ji Zhu	Zhejiang Cancer Hospital	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000631724	camrelizumab
D000068196	Albumin-Bound Paclitaxel
D000077146	Irinotecan

Ancestor Terms

ID	Term
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840

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